The company became aware of the warning letter on July 12, 2026, following a USFDA inspection of the facility conducted from March 3 to March 7, 2025. The warning letter concerns issues related to the Informed Consent Form (ICF) for the bioequivalence study.
Alembic Pharmaceuticals clarified that the observations do not pertain to data integrity. Following its preliminary evaluation, the company stated that the warning letter does not restrict operations at its Bioequivalence facility.
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The company is working with the clinical investigator to ensure an appropriate response to the USFDA is submitted within the required timeline.
Alembic Pharmaceuticals remarked, “Based on the company’s preliminary assessment, the warning letter does not impose any restriction on the operations of the company’s Bioequivalence facility.”
The company further stated, “No significant financial impact has been identified at this stage. We are assessing the situation and collaborating with the clinical investigator regarding the response to the USFDA.”
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Last month, Alembic Pharmaceuticals Ltd announced that it had received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL.
With this approval, Alembic Pharmaceuticals’ total USFDA approvals now stand at 243 ANDAs, including 223 final approvals and 20 tentative approvals.
The approved product serves as the generic equivalent of Hoffmann-La Roche’s Tamiflu Oral Suspension, 6 mg/mL, indicated for the treatment of acute, uncomplicated influenza A and B in individuals aged two weeks and older, as well as for the prevention of influenza A and B in those aged one year and above.
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According to IQVIA data, the product has an approximate US market size of $27 million for the 12 months ending March 2026, as reported by the company.
Shares of Alembic Pharmaceuticals Ltd closed at ₹830.65, down by ₹6.75, or 0.81%, on the BSE.
